Photomedicine Project 14: PBMT for Performance Enhancement in SOF

Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR)

Status: Enrolling

Conditions: Low-Level Laser Therapy; Photobiomodulation Therapy; Photomedicine; Performance Enhancement; Quadriceps; Special Operations Readiness

Treatments: Device: THOR3 training + sham PBMT; Device: THOR3 training + Photobiomodulation Therapy (PBMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06380179

USUHS.2023-126

Details and patient eligibility

About

Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators.

The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population.

The specific aims of this study are to:

1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population.

Enrollment: 116 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Active-Duty Special Forces Personnel (18-series)
• Able to read and understand English language for consent purposes
• Able to commit to study intervention and follow-up
• Able to participate in THOR3 coach-lead training, without restriction

Exclusion criteria

• Obese (body fat > 25%)
• Cardiovascular disease
• Use of select medications (e.g., statins, diuretics, hypertensive agents)
• Female
• Tattoo in treatment area (body region)
• Diagnosis with porphyria (light induced allergy) or photosensitive eczema
• Current use of medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
• Use of pacemaker/underlying cardiac disease
• Diagnosed with autoimmune disease(s)
• Albinism
• Peripheral Neuropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Photobiomodulation Treatment (PBMT)

Active Comparator group

Description:

PBMT will be delivered at 32-40 watts (W) (depending on participant skin pigmentation). PBMT will be applied to the quadriceps area. A study team member will use the quadriceps measurements of the treatment area to calculate the PBMT treatment time (approximately 5-20 minutes) and specified J/cm2. PBMT treatment will be provided 3 times per week, for 3 weeks.

Treatment:

Device: THOR3 training + Photobiomodulation Therapy (PBMT)

Sham PBMT

Sham Comparator group

Description:

The inclusion of sham PBMT will ensure all participant treatment procedures remain the same, with the exception of emission of photons (active treatment), thus, allowing for contribution of any differences between groups to be credited to the use of PBMT.

Treatment:

Device: THOR3 training + sham PBMT